UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005342
Receipt number R000006306
Scientific Title Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)
Date of disclosure of the study information 2011/03/30
Last modified on 2022/08/30 16:12:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)

Acronym

Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)

Scientific Title

Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)

Scientific Title:Acronym

Randomized phase II trial of CODE or amrubicin and cisplatin chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy for limited disease small cell lung cancer (JCOG1011, LD-SCLC/CODE vs AP)

Region

Japan


Condition

Condition

limited disease small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of CODE or 'Amrubicin plus cisplatin' chemotherapy following concurrent cisplatin, etoposide and accelerated hyperfractionation thoracic radiotherapy, and to select the promising arm for subsequent phase III trials

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival rate at one-year from 2nd registration

Key secondary outcomes

Response rate, complete response rate, overall survival , progression-free survival , and incidences of adverse event, grade 4 non-hematological toxicit, early death, and treatment-related death


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: etoposide 100mg/m2 days 1-3, cisplatin 80mg/m2 day 1, and thoracic radiotherapy 45Gy/30 fractions, followed by three cycles of cisplatin 25mg/m2 days 1, 8, vincristine 1mg/m2 day 8, doxorubicin 40mg/m2 day 1, and etoposide 80mg/m2 days 1-3. Prophylactic cranial irradiation 25Gy/10 fractions for patients with CR.

Interventions/Control_2

B: etoposide 100mg/m2 days 1-3, cisplatin 80mg/m2 day 1, and thoracic radiotherapy 45Gy/30 fractions, followed by three cycles of cisplatin 60mg/m2 day 1, and amrubicin 40mg/m2 days 1-3. Prophylactic cranial irradiation 25Gy/10 fractions for patients with CR.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) a histological or cytological diagnosis of small cell lung cancer
2) limited disease and clinical stage II-III
3) age between 20 and 70 years old
4) ECOG performance status of 0-1
5) having a measurable disease
6) the first treatment for small cell lung cancer
7) no prior chemothearpy or thoracic radiotherapy for any malignancies
8) a radiation oncologist determines that radiothearpy is possible
9 ) adequate organ functions defined as indicated below;
i) WBC of 4,000/mm3 or more
ii) Hemoglobin of 9.0 g/dL or more
iii) Platelet of 100,000/mm3 or more
iv) Total serum bilirubin of 1.5 mg/dL or less
v) GOT (AST) of 100 IU/L or less
vi) GPT (ALT) of 100 IU/L or less
vii) Serum creatinine of 1.3 mg/dL or less
viii) PaO2 of 70 torr or more at room air
10) written informed consent

Key exclusion criteria

1) synchronous or metachronous active malignancies
2) allergy to a contrast agent
3) any of the followings:
i) inappropriate secretion of antidiuretic hormone (SIADH)
ii) ectopic ACTH syndrome
iii) Lambert-Eaton myasthenic syndrome
iv) subacute cerebellar degeneration
v) paraneoplastic encephalomyelitis / sensory neuropathy
4) infection requiring systemic treatment
5) fever of 38 degrees centigrade or higher within 24 hours before registration
6) pregnant or lactating women
7) psychotic disorder
8) receiving systemic steroid therapy
9) unstable angina or myocardial infarction within the past 6 months
10) uncontrolled hypertension
11) uncontrolled diabetes mellitus or administration of insulin
12) interstitial pneumonitis or lung fibrosis identified by a chest X-ray, or severe pulmonary emphysema

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohide Tamura

Organization

National Cancer Center Hospital

Division name

Division of Thoracic Oncology

Zip code


Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, Japan

TEL

03-3542-2511

Email

JCOG_sir@ml.jcog.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ikuo Sekine

Organization

JCOG1011 Coordinating Office

Division name

Division of Thoracic Oncology, National Cancer Center Hospital

Zip code


Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, Japan

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp


Sponsor or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立病院機構旭川医療センター(北海道)
国立病院機構北海道がんセンター(北海道)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
国立病院機構西群馬病院(群馬県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
国立国際医療研究センター病院(東京都)
がん研究会有明病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
岐阜市民病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
愛知県がんセンター愛知病院(愛知県)
大阪市立大学医学部附属病院(大阪府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪市立総合医療センター(大阪府)
兵庫県立がんセンター(兵庫県)
倉敷中央病院(岡山県)
岡山大学病院(岡山県)
国立病院機構山口宇部医療センター(山口県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
熊本地域医療センター(熊本県)


Other administrative information

Date of disclosure of the study information

2011 Year 03 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28625642

Number of participants that the trial has enrolled


Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 03 Month 02 Day

Date of IRB

2011 Year 03 Month 18 Day

Anticipated trial start date

2011 Year 03 Month 30 Day

Last follow-up date

2017 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 03 Month 30 Day

Last modified on

2022 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name